A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility: Percent of referred who consent and meet study criteria
研究概览
简要总结
The purpose of this study is to learn whether a new family therapy using computer games with biofeedback might help people at clinical high risk for psychosis and their family members learn to experience less stress and have fewer mental health challenges.
详细描述
CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive control of emotion. The intervention and EM in CALMS were adapted from those used in Anger Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a randomized controlled trial at BCH, ACT and RAGE-Control relative to "sham" video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning.
In this feasibility study, family dyads will participate in 12 sessions aimed at
- enhancing engagement through the use of video and other games,
- enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and
- harnessing the power of the family to enhance contextual learning and the generality and duration of effects.
Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently Meet or Have Met Criteria of Prodromal Syndromes (COPS) according to the SIPS within the past 2 years
- •Estimated IQ > 70
- •Speak fluent English
- •Have at least one parent or adult family member who also speaks fluent English and is willing to participate
排除标准
- •Physical limitations precluding effective use of biofeedback videogames
- •Co-morbid psychiatric disorders, including substance disorders, but only if they better explain COPS symptoms or make participation counter-indicated.
- •Active suicidal ideation or attempts within the past 2 months unless being actively monitored and treated for this by a clinician
研究组 & 干预措施
CALMS
12 session family therapy using multi-user biofeedback games
干预措施: CALMS (Behavioral)
结局指标
主要结局
Feasibility: Percent of referred who consent and meet study criteria
时间窗: Up to six months
Enrollment
Feasibility: Percent of 12 sessions completed
时间窗: Up to six months
Engagement: Percent of sessions completed by consented and eligible participants
Feasibility: Counts of premature termination of intervention
时间窗: Up to six months
Feasibility: Self-report of Credibility/Satisfaction
时间窗: 12 week assessment or last assessment completed
Individual and family member self-report
Feasibility: Self-report of User Experience
时间窗: 12 week assessment or last assessment completed
Self-report of ability to learn/use technology to lower stress reactivity
次要结局
- Positive Symptom Score Change relative to Baseline(Weeks 4,8, and 12 Assessments)
- Change in Perceived Stress relative to Baseline(Weeks 4, 8, and 12 Assessments)
- Change relative to Baseline in Youth Perceptions of Relationship with Family Member(Weeks 4, 8, 12 Assessments)
- Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult(Weeks 4, 8, 12 Assessments)
- Change in Social and Role Functioning relative to Baseline(Weeks 4, 8, and 12 Assessments)
- Change in Global Functioning relative to Baseline(Weeks 4, 8, and 12 Assessments)
- Safety: Change in Hostility/Aggression relative to Baseline(Weeks 4, 8, and 12)
- Safety: Change in Video-game Addiction relative to Baseline(Weeks 4, 8, and 12)
- Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task(Baseline, Weeks 4,8, and 12)
研究者
Kristen Woodberry
Director, Program for Psychosocial Protective Mechanisms
Beth Israel Deaconess Medical Center